IRB Mythbusters – Exempt Research
The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB!
In this issue, “myths” surrounding exempt research are addressed. Access previous editions of IRB Mythbusters by visiting the “mythbusters” tag on our blog.
If my study is “exempt,” that means I don’t need to submit to the IRB.
FACT: While it is true that “exempt” technically means “exempt from the regulations,” institutions can implement institutional standards that go above and beyond regulatory requirements. At VCU, investigators are required to submit exempt research studies to the IRB for a formal determination of exemption, confirmation of the exempt category(ies), and to ensure basic ethical standards are met.
“Exempt” research differs from projects that are “Not Human Subjects Research” (NHSR). Exempt research projects are projects that DO meet the definition of “human subjects research,” but which fall into a category of research activities deemed to be so low-risk that the full set of regulations are not applied to these projects. While the full set of regulations are not applied to exempt research projects, VCU has institutional requirements for exempt research, including the requirement to submit exempt research to the IRB. NHSR projects, on the other hand, are projects that do NOT meet the definition of “human subjects research,” and therefore do not require any IRB review. At VCU, investigators are allowed to determine for themselves that a project is NHSR; however, determinations that a project is exempt must be made by the IRB, through an exempt submission in RAMS-IRB. You can learn more about how to determine if a project requires IRB review (i.e.: whether it is NHSR) on our “Activities Requiring IRB Review” webpage.
TIP: Think of IRB review as a continuum, with exempt review at the bottom, and full board review at the top. At the bottom, with exempt review, the IRB provides the least amount of oversight, as these are considered the least risky studies. Conversely, at the top, with full board review, the IRB provides the most amount of oversight, since these are considered to be the riskiest studies. Everything on the continuum is “human subjects research” that requires some kind of IRB review — it’s just that the extent of the review will vary depending on the risk level of the study. Be familiar with VCU’s institutional standards for exempt research so you know what to expect when submitting an exempt study to the IRB. VCU’s exempt research standards can be found in Written Policy and Procedure (WPP) VIII-1. You can also learn more on our “Types of Review” webpage.
Anonymous, online surveys don’t count as “human subjects research” and therefore don’t need to be submitted to the IRB.
FACT: One of the ways an individual becomes a “human subject” in a research study is when information is collected about them through interaction or intervention. The act of an individual completing a survey is considered an interaction with the researcher, regardless of whether that interaction happens in-person, remotely, or asynchronously. The fact that the dataset resulting from the survey is anonymous does not have any bearing on whether IRB review is required. Any time a project meets the regulatory definitions of “research” AND “human subjects,” IRB review is required. This type of research may qualify as an exempt research project, but at VCU, exempt projects must be submitted to the IRB for review.
TIP: Be sure to understand when IRB review is required for a project by reviewing the regulatory definitions of “research” and “human subjects.” You can learn more on our “Activities Requiring IRB Review” webpage. You can learn more about exempt research and the exempt categories on our “Types of Review” webpage and in Written Policy and Procedure (WPP) VIII-1.
The new exempt category 4(iii) applies to collection of identifiable, secondary biospecimens.
FACT: Under the 2018 Common Rule, exempt category 4 was indeed expanded into four subcategories, to allow for more types of secondary research to qualify under that category. Subcategory 4(iii) allows for the collection of identifiable, secondary health information, provided the data are protected and regulated by HIPAA. However, this subcategory does NOT allow for the collection of identifiable, secondary biospecimens.
Exempt category 4 has been divided into 4 subcategories under the 2018 Common rule:
- Exempt Category 4(i) — use of publicly available secondary data/biospecimens.This subcategory can apply to biospecimens, both identifiable and de-identified.
- Exempt Category 4(ii) — use of secondary data/biospecimens when data/biospecimens are collected anonymously (i.e.: no identifiers recorded at any time during the conduct of the study, and no code key linking data to identifiers is created). This subcategory can apply to biospecimens, but only if those biospecimens are NOT identifiable at ANY point in the research database.
- Exempt Category 4(iii) — use of identifiable secondary data, provided the data are regulated and protected by HIPAA. This category does NOT include biospecimens, regardless of identifiability.
- Exempt Category 4(iv) — use of government-generated secondary data for research which is conducted by, or on behalf of, a Federal department or agency. This category does NOT include biospecimens, regardless of identifiability.
If your research involves using biospecimens, but you intend to store the biospecimens in such a way that the biospecimens cannot be linked back to donors, then you may qualify for exempt review under exempt category 4(ii). Research involving identifiable secondary biospecimens (which are not publicly available), however, will most likely need to be reviewed at the expedited level, rather than the exempt level.
TIP: Carefully review the requirements for exempt category 4, by looking at our “Types of Review” webpage and at Written Policy and Procedure (WPP) VIII-1. It may also be helpful to review VCU’s definitions relating to data identifiability, in order to understand if your data/specimens are identifiable, de-identified, or anonymous. If you are unsure whether your secondary biospecimen research qualifies for exemption or must be reviewed at the expedited level, request a consultation with IRB staff (before submitting), or contact your IRB coordinator (after submitting).
You can find your assigned IRB Coordinator in RAMS IRB:
Once you know who your IRB Coordinator is, you can find their contact information on our website. If you contact the office or any member of the office by telephone and are unable to reach someone directly, please leave a message. All calls will be returned in a timely manner.